Transcutaneous electrical nerve stimulation device and method using microcurrent

ABSTRACT

A transcutaneous electrical nerve stimulation device and method using a microcurrent with a carrier signal and a square wave form for promoting cell repair and/or healing. It has been found that applying particular wave forms of direct current with a carrier wave signal with specified intervals promotes cell healing especially in treatment of macular degeneration. This method and nerve stimulation device is packaged to require no input from a user and a user must only apply the electrodes to the correct part of the body and start the preprogrammed sequence of electrical currents. The method involves applying bursts of direct current at higher frequencies for shorter periods of time followed by lower frequency bursts of electrical current for longer periods of time.

RELATED APPLICATION

This is a divisional application of U.S. patent Ser. No. 10/457,857filed Jun. 10, 2003 which claims the benefit of U.S. provisionalapplication 60/388,577 filed Jun. 13, 2002.

FIELD OF THE INVENTION

This invention relates generally to a transcutaneous electrical nervestimulation (TENS) apparatus for use for therapeutic purposes. Thisdevice proposes using electrical current in the microamp range (lessthan one milliamp) for specific wave forms and carrier waves. Thetreatment duration is of a definite length and sequence with proposedautomatic controls. The wave form, the current, and the duration oftreatment are all designed to maximize therapeutic benefits.Microcurrent is defined as current below one milliamp. For paintreatment, it is believed that the microcurrent blocks neuraltransmission of pain signals and stimulates release of endorphins knownto be naturally occurring pain relieving chemicals. The combination ofthe blocking of the pain signals and release of the endorphins providesfor relief of both chronic and acute pain. It is also believed thatmicrocurrent stimulation can promote healing or cell repair. The exactmechanism of promotion of cell repair is unknown. However, it isbelieved that this can be done by increasing blood vessel permeability,increasing adenosine triphosphate levels, or restoring cellularelectrical balances by changing electric potentials across cellmembranes.

BACKGROUND OF THE INVENTION

One TENS device is described in the Rossen U.S. Pat. No. 4,989,605. Itis believed this device has been sold on the market by the trade name“MicroStim”. The Rossen '605 patent discloses a microcurrent TENS unitthat uses a unique wave form. It is proposed the current is from 250microamps up to about 900 microamps with a peak current of sixmilliamps. The current is applied through a pair of electrodes in theform of high-frequency monophasic bursts of a direct current with acarrier signal from around 10,000 Hz to 19,000 Hz. The signal ismodulated at a relatively lower frequency (0.3 Hz up to 10,000 Hz).These modulated carrier signals are from about 0.05 seconds to 10seconds in duration with above one second being the preferred duration.The electrodes are reversed as simulating a biphasic form yet thecharacter is a monophasic DC signal. The Rossen patent is for palliativepain treatment only.

The Wallace U.S. Pat. No. 5,522,864 proposes that macular degenerationor other ocular pathology may be treated by placing a positive electrodeof a direct microcurrent source in contact with the closed eyelid of thesubject and placing a negative electrode away from the eye of thesubject, preferably on the neck of the subject. These electrodes apply aconstant direct current of 200 microamps for approximately 10 minutes.It is proposed that this device can be portable and battery powered,hence allowing a subject undergoing the treatment to ambulate during thetreatment. The Wallace patent proposes using microcurrent to treatmacular degeneration but does not disclose the mechanism by whichpositive results are obtained.

The Jarding et al. U.S. Pat. No. 6,275,735 proposes digital control ofthe modulation frequency of the microcurrent signal. The modulationfrequency is controlled by a digital data word. A controller is coupledto a digital analog converter and supplies the digital analog converterwith digital data words to generate an electrical signal for themicrocurrent stimulation therapy. It is believed that this form ofmicrocurrent therapy may be particularly useful in macular degeneration.More specifically, the Jarding patent proposes that adenosinetriphosphate levels in cells can be affected by appropriate electricalstimulation. Jarding proposes that electrical stimulation to the cellsincreases blood vessel permeability, increasing ATP levels andincreasing protein synthesis. Therefore, Jarding concludes thatmicrocurrent stimulation can help rejuvenate cells in the retina to slowor stop degeneration of the eye due to age-related macular degeneration.Therefore, Jarding proposes a computer controlled electrical stimulationto maximize therapeutic benefits by varying the types of wave forms andfrequency ranges used in the therapy.

Another problem present in the use of TENS units for therapeutic orpalliative effect is patient compliance. Wingrove patent U.S. Pat. No.5,800,458 proposes a compliance monitor to determine if the patient isusing the TENS unit in accordance with instructions or prescriptions.Another problem with conventional TENS units is they can be bulky ordifficult to control. This can especially apply to individuals who havesome disability or who are in acute pain. Michelson et al. U.S. Pat. No.6,445,955 proposes a miniature wireless TENS unit. A remote controllersends transmission signals to a receiver within an electronic modulewith the TENS unit allowing the patient to program specific units in aspecific way. The TENS unit itself may be incorporated within a bandageor electrode package and worn directly on the patient's body.

It has also been proposed, at least in a research context, that thewrong current levels used in transcutaneous electrical nerve stimulationcan actually reduce ATP levels and may cause more harm than good.Research by Ngok Chen would demonstrate, at least in rats, that currentlevels in the microamp range tended to increase ATP concentration incells while currents in the milliamp range tended to lower ATPconcentration in cells. (Sec Chen, The Effects of Electrical Current onATP Generation, Protein Synthesis, and Membrane Transport in Rat Skin,Clinical Orthopedics Research, 171, November-December 1982, pp. 264-271)It has also been suggested by Thomas W. Wing, D. C., N. D. that directcurrent employing a carrier wave with a low frequency is very helpfultriggering the repair process in muscles. Wing suggested only very lowlevels of stimulation are required if the effect of the directelectrical current at a low frequency was the triggering of the body'snatural repair cycle. Wing suggests that low frequencies of 0.1 to 0.3Hz produce lasting therapeutic effects, but pain relief is more rapid athigher frequencies in the 10 to 100 Hz range. Thomas W. Wing, D. C., N.D. Chiropractic Economics, March/April 1987. The Food and DrugAdministration has approved the use of TENS units for symptomatic reliefof chronic pain and to manage post surgical traumatic pain problems. Thetherapeutic use to treat macular degeneration proposed by Wallace et alin the '864 patent is an off label use of a TENS device, that is, thisuse is not approved by the FDA. However, in order to obtain FDA approvalfor a TENS unit for treatment of degenerative diseases such as maculareye disease, tissue repair, and cell regeneration, require proof ofeffectiveness. Proof is obtained through double blind, randomized, andmulti-site clinical trials. It is believed such trials are underway todocument effectiveness of a TENS unit for the treatment of age relatedmacular degeneration.

The use of a TENS unit both for palliative and therapeutic treatment iswell established, but the precise mechanism by which it operates is notfully understood. This means that even small differences in how anelectrical current is applied can have unpredictably large changes inthe therapeutic outcome. That is to say, a current of 200 microampsmight be therapeutic, while a current of 400 microamps might actually beharmful. By the same token, such factors as whether the current isapplied in a wave form, whether the polarity of the current alternates,and the like all can have important impacts in either the palliative orthe therapeutic effect. Consequently, the optimal use of a TENS unit foreither palliative or therapeutic effects proceeds more byexperimentation than by theoretical design. That is to say, there is notheory by which one can design an ideal or maximally beneficialtreatment modality for a particular TENS unit, then experiment toconfirm the correctness of the program. Theory may point one in theright direction, but then an inventor must use intuition, clinicaljudgement, and experimentation to arrive at a therapeutic program givingmaximum benefits.

Despite this earlier work there is still need for a TENS unit andtreatment method to meet specific goals and needs. First, in the correctmethod, the TENS units must always operate in a current range thatmaximizes the benefits of the electrical nerve stimulation. Second, theduration and frequency of the electrical stimulation must be controlledto maximize the benefits. Third, control of the TENS unit should bedesigned to maximize compliance of a patient. Therefore, it is an objectof the current invention to provide a fully automated and computercontrolled microcurrent stimulation device. It is a further object ofthe invention to administer a therapeutic electrical current in themicroamp range, always less than one milliamp. It is a further object ofthe invention that the current be administered in a square wave form ina sequential pattern of specific electrical bursts with frequenciesbetween 0.1 Hz and 300 Hz. It is a further object of the invention tocontrol the duration of the application of each electrical currentbursts with the specified frequency for a specific period of time andsequence the application of the current controlled by an internalcontrol to minimize patient compliance issues and to maximize benefit.It is a further object of this invention to periodically reverse thepolarity of the current flow at specific intervals. It is a furtherobject of this invention to give visual and audible cues as to thetreatment being administered at any given time. It is an object of theinvention to provide minimal controls or requirements for patient inputor control. It is a further object of the invention that the TENS unitwill be ergonomically designed and easily used by those with physicaldisabilities.

SUMMARY OF THE INVENTION

The present consists of a microcurrent stimulator ordinarily housed in arigid casing. Inside that casing are controls to produce and apply amicrocurrent transcutaneous electrical nerve stimulation. The controlsare preprogrammed to provide a therapeutic level of electrocurrent inthe microamperage range in a square wave form with a specific sequentialpattern of specific electrical bursts with specific frequencies and toreverse the current flow at specific time intervals by reversing theelectrode polarity. The application of the specific electrical carrierfrequencies and microamperage current is controlled for duration and issequenced by the control. Ordinarily, there will be both visual andaudible cues given to a user by the microcurrent stimulator. Themultiple frequencies begin with a higher frequency and work down to alower frequency.

This microcurrent stimulation unit has minimal settings adjustments orcontrols for patient use. It is believed the microcurrent stimulationdevice should be preset by a physician or other clinician at specificdurations and frequencies to maximize therapeutic benefit. A specificcarrier frequency would be used in the range of 10,000 Hz to 15,000 Hz.The current will be delivered in the microamp range less than onemilliamp. A square wave form will be employed. Specific electricalbursts with specific frequencies, no more than 300 Hz and no less than0.1 Hz, will be employed. A typical pattern of bursts would be a 292 Hzfrequency applied for 60 seconds, a 30 Hz frequency applied for 120seconds, a 9.1 Hz frequency applied for 180 seconds, and a 0.3 Hzapplied for 360 seconds. The electrode polarity will be reversed everytwo seconds. A therapeutic program will ordinarily be in the range of 12minutes of duration according to a pre-programmed, pre-set treatmentsequence with controlled current levels and wave forms to have thegreatest therapeutic value. As the therapeutic program is beingadministered, the unit will have visual and audible waves of signalingto a user the progress of the therapy program. The unit will have waysof alerting a user to malfunctions or to low-battery. Other features andadvantages of the invention will become apparent in the DetailedDescription of the Drawings, which follow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows the microcurrent stimulation device.

FIG. 2 is a block diagram of the essential components of themicrocurrent stimulation device.

FIG. 3 is a circuit diagram of an embodiment of the current invention.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 shows the microcurrent stimulation device (10). Ordinarily, thereis a box (11) with various components and controls. Connected to the box(11) are at least two electrodes (22) and (22A) that connect to the box(11) as part of the microcurrent nerve stimulation device (10). If thepolarity of the current is reversed as part of a treatment method, thenmore than two electrodes may be employed. Electrodes (22) and (22A)connect by means of wires (20) and (20A) and probes (15) and (iSA) toelectrode jacks (14) and (14A) in the front of the box (11). Electrodes(22) and (22A) will be applied to a user completing an electricalcircuit which allows a microcurrent to pass from one electrode throughthe body of the user to the other electrode to complete the circuit.Contained within the box (11) are control circuitry and microprocessorswhich may be programmed to provide particular types of current inparticular wave forms, as will be explained later in the application. Onthe front of the box (11) is a turn dial control knob (60) that controlsthe amount of current passing through the electrodes (22) and (22A) andfrom jacks (14) to (14A) or vice versa. There is a slide on/off switch(40) and an indicator light (41) that indicates when the microcurrentnerve stimulation device is operating. Ordinarily, batteries will supplythe power, which are contained in the battery unit (30) on the front ofthe box (11). Alternately a direct current to power the microcurrentnerve stimulation device (10) may be supplied through the power jack(32), shown on the side of the box (11). When the indicator (41) is dimor not on, it means that the batteries (30) are low and need replacingor that no power is being supplied through the power jack (32). Disposedon the right-hand side of the box (11), from the viewer's perspective,are four program indicator lights (50, 51, 52, 53).

To use the microcurrent nerve stimulation device (10), the user willordinarily apply the electrodes (22) and (22A) to a prescribed place asdetermined by a health care provider. The leads (15) and (15A) will beconnected to the input jacks (14) and (14A). The on/off switch (40) willturn the device on and the control knob (60) will be adjusted by a userto the appropriate amount of current. Typically, a user will turn thecontrol knob (60) to a level of current where a mild tingle indicatingelectrical current will be felt, then the control knob (60) will beadjusted downward to reduce the amount of current to where the currentis no longer a perceptible tingle to a user. The microcurrent nervestimulation device (10) will then begin to follow a pre-programmedsequence in which current will be provided with a particular frequencyand wave form. In the preferred program, current will be provided in asquare wave form at a frequency of 292 Hz for 60 seconds. During those60 seconds the program indicator light (50) is lit, which advises theuser that the program is underway. When the current applied at 292 Hzfor 60 seconds stops, an audible tone will sound and the next step inthe therapy program will begin. Here, program indicator light (51) willlight, current will be provided at 30 Hz for 120 seconds. At theconclusion of this step in the therapy program, a tone will sound again.The program indicator light (51) will dim and program indicator light(52) will light. This indicates that current will be provided at 9.1 Hzfor 180 seconds. A third tone will sound indicating that step in thetherapy program is over. Program indicator light (52) will dim andprogram indicator light (53) will light up. Current will be provided for0.3 Hz for 360 seconds. At the conclusion of this therapy, a tone willagain sound and the therapy program will end and the microcurrent nervestimulation device (10) will stop the therapy program. During thetherapy program the polarity of the electrodes (22) and (22A) willreverse every two seconds. At this point, a user will remove theelectrodes (22) and (22A), turn the on/off switch (40) to off, and themicrocurrent nerve stimulation device (10) is ready to begin anothertreatment program or maybe stored until required for further use.

FIG. 2 shows a block diagram of the electrical components for anembodiment of the microcurrent stimulation device (10) as seen inFIG. 1. A more complete description of electrical components of oneembodiment is shown in the circuit diagram in FIG. 3. There is a directcurrent power supply (200). In a commercial embodiment, this could be anine-volt battery or household current adopter to supply nine volts to aconnection or jack provided on the microcurrent stimulation device (10)as shown in FIG. 1. Current flows through an on/off switch (205) tovoltage convertor (210) to a regulator (220) and to a oscillator (230).Current flows from the regulator (220) and oscillator (230) to afrequency divider (250). A constant current source (260) receivescurrent from the frequency divider (250) and from the voltage convertor(210) then passes from the constant current source to a first electrode(260). A circuit is completed from the first electrode (260) through thepatient (not shown) to a second electrode (265). Current returns to theconstant current source (260) to the voltage convertor (210) through anamplitude control (70) and then to the power source (200) to completethe circuit.

FIG. 3 is a circuit diagram of a commercial embodiment of a microcurrentstimulation device (iO). Standard symbols and terminology are used inlabeling the circuit diagram shown in FIG. 3. For simplicity of thediagram, the potentiometer labeled “VR1” is shown in two places on thecircuit diagram, but in the actual circuit there is only one VR1potentiometer. This is indicated by the letter “A” with a circle aroundit and the arrow. This points to the same part. It will be understoodthat there is not two potentiometers, but only one from 5K to 85Kresistance. A materials list is given below. The standard devices inFIG. 3 are labeled in accordance with the materials list. Controls areprovided by five computer chips. Four chips are a high-densityphotocoupler chip. One chip that has been found to work in practice ismanufactured by the Sharp Company and assigned product #PC817X. One chipis a programmable read only memory chip. One chip that has been found towork in practice is manufactured by Microchip. It is a 28 Pin, 8 BitMicro Controller Chip and is assigned part #P1C16C628-04. This chip isequipped with timers, data memory, and other features required toproduce and control appropriate microcurrent output and polarity. Itwill be appreciated by one of skill in the art that such standard thingsas diodes, resistors, capacitors, transformers, transistor switches andthe like, which appear on the circuit diagram, can be varied withoutdeparting from the essentials of the invention, which is to producemicrocurrents with specified wave forms and carrier frequencies timed ina way to maximize the benefit and to induce patient compliance.MATERIALS LIST RESISTORS R₁ - JUMPER WIRE (no resistor) R₂ - 680 Ω R₃ -680 Ω R₄ - 680 Ω R₅ - 680 Ω R₆ - 1 Ω/1 W R₇ - 1 Ω/1 W R₈ - 1 K/2 W R₉ -10 KΩ R₁₀ - 2K2 R₁₁ - 330 Ω R₁₂ - 3K9 R₁₃ - 390 Ω R₁₄ - 1 KΩ R₁₅ - 3K3R₁₆ - 22 kΩ R₁₇ - 10 kΩ R₁₈ - 10 kΩ DIODES D₁ - 4007 D₂ - 4007 D₃ - 4007D₄ - 4148 D₅ - 4148 D₆ - 4148 D₇ - 4148 BUZZER BZ1 - 080 ON-OFF SwitchCAPACITORS C₁ - 22 pf C₂ - 22 pf C₃ - 220 μf/16 v C₄ - 104 pf C₅ - 100μf/16 v C₆ - 104 pf TRANSISTORS Q₁ - C1815 Q₂ - B649 Q₃ - B649 Q₄ - DB82Q₅ - D471 Q₆ - D471 INTEGRATED CIRCUIT CHIPS IS01 - PC817 IS02 - PC817IS03 - PC817 IS04 - PC817 PIC 16C628 - 04/SF D21605M UT78L05 LEDS LED₁ -Dipole LED LED₂ - Green LED 5 mm LED₃ - Green LED 5 mm LED₄ - Green LED5 mm LED₅ - Green LED 5 mm CRYSTAL OSCILLATOR H8.000E4 2 TRANSFORMERSPOT (VRI) 5 k (85 k) PRESET VARIABLE RESISTANCE SVRI - 103 (10 k) SVR2 -503 (50 k) ON-OFF Switch

The treatment protocol employing the embodiment described in FIGS. 1, 2,and 3 can be used specifically to treat macular degeneration of an eye.It is believed this operates, at least in part, by stimulating cellactivities producing an increased ATP concentration. In this specifictreatment protocol, a patient will first prepare the appropriate skinarea by careful washing and drying to remove skin oils, cosmetics, orother foreign materials from the skin surface. A patient will connect apair of electrode pads (not shown) to the electrode input jacks (14) and(14A) on the microcurrent nerve stimulation device (10). The electrodepads (not shown) ordinarily have a sticky surface so that they willadhere to the skin. An electrode pad is placed on the back of each hand.An electrode pad is placed on the closed eyelid of each eye. If themicrocurrent nerve stimulation device (10) is not already on, thecontrol switch (40) will be turned to on and the intensity knob will beadjusted to intensity to a preset figure on the intensity knob, usually‘8’. Then the knob will be individually adjusted by a user to thatuser's comfort level according to a set of instructions provided withthe unit. Only current in a predetermined microamperage is applied.

The microcurrent nerve stimulation device (10) is programmed to deliver12 minutes of treatment for treatment of macular degeneration. Themicrocurrent nerve stimulation device (10) is also programmed to audiblynotify a user as the treatment proceeds at each stage of the treatment.For treatment of macular degeneration, there will be a first current ata frequency of 292 Hz with a square wave form for 60 seconds. Theamperage output will be no more than 999 microamps. When the 60-secondapplication at 292 Hz is complete, a first beep will sound. Themicrocurrent nerve stimulation device (10) will automatically start asecond microcurrent stimulation at 30 Hz for 120 seconds. Ordinarily,the amount of amperage will not be adjusted and will remain constantthroughout the treatment. When the 120-second application is complete, asecond audible tone will sound and the third period of microcurrentstimulation will begin. Again, it will be controlled automatically bythe microcurrent nerve stimulation device (10) to apply 9.1 Hz frequencyat 180 seconds. A third tone will sound and the microcurrent nervestimulation device (10) will start a fourth sequence at a frequency of0.3 Hz for 360 seconds. At the completion of this, a fourth tone willsound, which will also notify the user that the treatment is complete.During the treatment the microcurrent nerve stimulation device (10) willreverse the polarity of the electrodes every two seconds. If a userexperiences discomfort during application of the treatment, theintensity knob (60) will be adjusted downward to a position where theuser will no longer experience discomfort. The treatment is ordinarilyadministered twice a day once in the morning and once in the evening. Ithas been found in practice that stimulating with a square wave form forthe intervals and frequencies described above is an effective treatmentfor macular degeneration.

Case Histories

Case history #1 is an eighty-year-old white female with a five-yearhistory of age-related macular degeneration. The diagnosis was confirmedby a board certified retinal specialist ophthalmologist. The patient'smedical history for her eyes indicated she was pseudophakic in both eyeswith cataract surgery seven years prior to treatment. The chiefcomplaint was decreased central vision acuity progressing to the pointof loss of driving privilege. The remainder of the medical history wasunremarkable and the patient's other medications were unremarkable.

Entrance visual acuity on her initial examination was 20/80 OD and20/160 OS. A computerized Macular Mapping Test (MMT) was performedshowing a central scotoma in the right eye with an adjusted score of70.50 and a central scotoma in the left eye with an adjusted score of69.00. Pupils are reactive and equal and her external and internal eyeexam were within

normal limits with the exception of IOL's OU and age-related maculardegeneration. Based upon the confirmed diagnosis age-related maculardegeneration, the patient was started on microcurrent stimulationtherapy. Her treatment protocol consisted of two, twelve minute sessionseach day. Each session consisted of 500-800 microamps of current at fourseparate electrical frequencies. 292 Hz for 60 seconds, 30 Hz for 120seconds, 9.1 Hz for 180 seconds, and 0.3 Hz for 360 seconds.

After four days of microcurrent stimulation therapy, the patientreported an improvement in her subjective ability to see. Visual acuitywas reevaluated and found to have improved to 20/60 OD and 20/100 OS.MMT was repeated and showed a decrease in the size of the centralscotomas in both eyes with adjusted scores of 96.50 OD and 93.00 OS. Thetherapy was continued with two, twelve minute sessions each day and atsix weeks the patient was evaluated by her original retinal specialist.He confirmed that her visions had indeed stabilized and improved.

Case history #2 is a 55 year old professional white male. The patientshad a two-year history of age-related macular degeneration with thediagnosis confirmed by three separate ophthalmologists. He was onmedical disability from his employment because of visual disability. Themedical history for the patient was otherwise unremarkable and no othereye pathology was reported.

Entrance visual acuity measured 20/40 OD and 20/50 OS. Amsier gridtesting reveals metamorphopsia in both eyes. Pupils are reactive andequal. The fundus exam reveals drusen in the posterior pole of both eyeswhich is indicative of macular degeneration. The rest of the ocular examis within normal limits with no other ocular pathology present. Basedupon the confirmed diagnosis age-related macular degeneration, thepatient was started on microcurrent stimulation therapy. His treatmentprotocol consisted of two, twelve minute sessions each day. Each sessionconsisted of 500-800 microamps of current at four separate electricalfrequencies. 292 Hz for 60 seconds, 30 Hz for 120 seconds, 9.1 Hz for180 seconds, and 0.3 Hz for 360 seconds.

After five days, the patient was reevaluated. Visual acuity had improvedto 20/25 OD and 20/30 OS. There had been a subjective improvement in thepatient's ability to read comfortably and without visual stress. Amslergrid testing revealed persistent metamorphopsia, however it was lesspronounced. The patient continued with two, twelve minute therapysessions each day and was able to resume work. Upon reexamination by hisoriginal ophthalmologist, he was told that his macular degeneration hadactually reversed and his vision had improved.

1. A microcurrent transcutaneous electrical stimulation device forpromotion of healing and cell repair comprising: (a) at least a firstand a second electrode for making surface contact applying an electricalcurrent though a user's skin; (b) means for applying an electricalcurrent across said first electrode and said second electrode, saidelectrical current applied using a direct current carrier signalfrequency from 10,000 Hz, to 20,000 Hz, said electrical current in arange from 1 microamp to 1,000 microamps; (c) means for modulating saidelectrical current on and off at a preset frequency for a preset periodof time, said preset frequencies from 0.1 Hz to 400 Hz; (d) said presetfrequency starting at a first frequency for a first period of time withat least a second frequency less than said first frequency and appliedfor a second time said second time longer than said first time; and (e)means for controlling said means for applying and said means formodulating so that said first and said second preset frequencies areapplied automatically by said means for controlling without requiringinput from a user.
 2. The device of claim 1 wherein there is a thirdpreset frequency, said third preset frequency lower than said secondpreset frequency and a third preset period of time, said third presetperiod of time longer than said second preset period of time.
 3. Thedevice of claim 2 wherein there is a fourth preset frequency and afourth preset period of time, said fourth preset frequency lower thansaid third preset frequency and said fourth period of time longer thansaid third period of time.
 4. The device of claim 3 wherein said firstfrequency is more than 100 Hz but less than or equal to 400 Hz and saidfirst period of time is more than 30 seconds but less than 90 seconds.5. The device of claim 4 wherein said second frequency is more than 10Hz but less than or equal to 100 Hz and said second period of time ismore than 90 seconds but less than 150 seconds.
 6. The device of claim 5wherein said third frequency is more than 1 Hz but less than or equal to10 Hz and said third period of time is more than 180 seconds but lessthan 270 seconds.
 7. The device of claim 6 wherein said fourth frequencyis more than 0.1 Hz but less than or equal to 1 Hz and said fourthperiod of time is more than 270 seconds but less than 500 seconds. 8.The device of claim 7 wherein said means for modulating further includemeans for applying said preset frequency in a square wave form.
 9. Thedevice of claim 8 wherein said means for applying electrical currentfurther includes means for reversing the polarity of said electricalcurrent at a preset interval of time.
 10. The device of claim 9 whereinsaid reversal of polarity happens at a frequency no greater than onereversal per second but no less than one reversal of polarity every fiveseconds.